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American law requires that certain drugs and biological products must be labelled very specifically. Title 21, Part 201.57 (9)(i) of the Code of Federal Regulations lists specific requirements regarding the labeling of drugs with respect to their effects on pregnant populations, including a definition of a "pregnancy category".
Code of Federal Regulations, Title 21, Part 312, Investigational New Drug Application ; Code of Federal Regulations, Title 21, Part 201.56 (and Part 201.57) CDER Guidance for Industry. Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format. CDER Guidance for Industry.
21 CFR Part 11 CellPort: CellPort Software, LLC: 2021 United States: 21 CFR Part 11 Genemod [6] Genemod, Inc. 2018 United States: 21 CFR Part 11 Chemia ELN: Chemiasoft Pvt ltd: 2016 India [21 CFR Part 11] Logilab ELN: Agaram Technologies: 2003 India: 21 CFR Part 11 & Data Integrity: LabCollector [7] AgileBio: 2002 France [8] Labii [9] [10 ...
Another study using National Cancer Database (NCDB) data from 2007 to 2012 found a 5.5 percentage point decrease in late-stage (stages III/IV) cervical cancer diagnosis for women aged 21–25 after DCE, and an overall decrease of 7.3 percentage points in late-stage diagnosis compared to those aged 26–34. [239]
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies.Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, [1] cosmetics, [2] pharmaceutical products, [3] dietary supplements, [4] and medical devices. [5]
The Bureau of Safety and Environmental Enforcement (BSEE / ˈ b ɛ s i / "Bessie") is an agency under the United States Department of the Interior. [1] Established in 2011, BSEE is an agency responsible for improving safety and ensuring environmental protection in the offshore energy industry, mainly natural gas and oil, on the United States Outer Continental Shelf (OCS). [2]
The Kivu Ebola epidemic [note 2] was an outbreak of Ebola virus disease (EVD) mainly in eastern Democratic Republic of the Congo (DRC), and in other parts of Central Africa, from 2018 to 2020. [10]
The Order of the Federal Republic (OFR) is one of two orders of merit, established by the Federal Republic of Nigeria in 1963. It is senior to the Order of the Niger. [1] [2] ...